The advent of a new class of drugs known as biologics has revolutionized the treatment of rheumatoid arthritis (RA). These drugs, which include Cimzia, Enbrel, Humira, Kineret, Orencia, Remicade, Rituxan, and Simponi, must be given via self-injection or intravenous infusion in the doctor’s office or hospital. They also can be expensive and are not always covered by insurance.
For those reasons and more, researchers are working to develop oral biologics -- biologics you could take as a pill.
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RA, an autoimmune disease affecting 2 million people, happens when the body engages in friendly fire against its own joints and tissues, causing inflammation, pain, and joint damage. Drugs called disease-modifying antirheumatic drugs (DMARDs) and biologics stop the progression of RA, reducing inflammation and halting joint damage.
“It used to be that our waiting rooms were full of patients with deformities in wheelchairs and some whose hands were so deformed that they didn’t even look like hands, and we don’t see that anymore mainly because of the biologics,” says Dalit Ashany, MD, a rheumatologist at the Hospital for Special Surgery in New York City.
However, she says, many people with RA resist getting injections and IVs -- the only way that biologics are available. It would be much simpler to be able to take biologics in pill form than to have to self-inject the drugs or go to the hospital for infusion.
“Pills are also much cheaper than injections and infusions,” she says. “Insurance companies make us go through hoops to prove that RA patients need the drugs, and some can’t afford them without coverage.”
Biologics are made using large protein molecules that are taken from living things. This involves a more complex and expensive manufacturing process. Generic versions would be cheaper, but these drugs are so new that they are also protected under patent. Furthermore, the FDA does not have a process in place for approving generic biologics.
Oral Biologics: In the Pipeline?
Eric Matteson, MD, chair of the department of rheumatology at the Mayo Clinic in Rochester, Minn., is not 100% convinced that we will see oral biologics in the near future.
Two of the main roadblocks in the quest to develop oral biologics have been that these protein molecules are too large to be absorbed if taken orally, he says. Then they are no longer active if they get broken down when they go through the gut.
There are a handful of oral biologics in the pipeline showing promise, Ashany says. Some target proteins called kineases, which can trigger the inflammation that is a hallmark of RA.
The inflammation process basically causes a domino effect, where one cell or substance activates the next one, and so on down the line. These new drugs target different parts -- or dominoes -- in the cascade.
One such drug blocks syk kinase or spleen tyrosine kinase. Some research has suggested that this drug may work in people who do not respond to TNF blockers, a commonly used type of biologic, she says.
Another type of biologic (called a JAK inhibitor) that could be taken orally also is doing well in early trials, Ashany says.
“We are quite excited about the new orals,” says Philip Mease, MD, rheumatologist at Seattle Rheumatology Associates. Mease has done several studies on one JAK inhibitor that is in the pipeline. But he notes that there are still many questions that need to be answered about these drugs.
Possible side effects may include anemia, rare effects on white blood cell count, and some elevation of blood fats, so monitoring would be necessary.